Cefdinir

Product NDC: 0781-2176
11-digit product format: 007812176
Labeler code: 0781
Product ID: 0781-2176_977d4566-20b3-4909-ad00-6cbea017798d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: CAPSULE
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA065330
Marketing category: ANDA
Marketing start: 2007-04-06
Substance: CEFDINIR
Active strength: 300 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065330-001	CEFDINIR	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A065330-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065330-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065330-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065330-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065330-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065330-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065330-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065330-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065330-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065330-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065330-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065330-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065330-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065330-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065330-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065330-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065330-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065330-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065330-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065330-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065330-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065330-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065330-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065330-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065330-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065330-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065330-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065330-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065330-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065330-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065330-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065330-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065330-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065330-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065330-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065330-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065330-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065330-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065330-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065330-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065330-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cefdinir
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFDINIR	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CI0FAO63WC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200346	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
38f6adf7-e26c-4764-8ec9-360813874dd4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d3e72f63-2c41-955f-f4ce-e90c6403e67c	Product name	2	20210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1	Product name	2	20210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0781-2176-01	Cefdinir	100 in 1 BOTTLE	CAPSULE	100	14
0781-2176-60	Cefdinir	60 in 1 BOTTLE	CAPSULE	60	14
0781-2176-64	Cefdinir	3 in 1 CARTON	CAPSULE	3	14
0781-2176-64	Cefdinir	1 in 1 CARTON	CAPSULE	1	14
0781-2176-69	Cefdinir	5 in 1 CARTON	CAPSULE	5	14
0781-2176-69	Cefdinir	10 in 1 BLISTER PACK	CAPSULE	10	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-2176-60	EA - Each	0781-2176	e6a12472-9d90-432d-af7b-ab10203c483b	1	2012-07-24
0781-2176-64	EA - Each	0781-2176	b6385fc7-a050-40a3-a9ab-2ea11c138fe7	1	2012-07-24
0781-2176-69	EA - Each	0781-2176	ac043ca3-3201-416f-a8c1-d1b406d3c436	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR CAPSULE [SANDOZ INC]	11
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR CAPSULE [SANDOZ INC]	11
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CEFDINIR CAPSULE [SANDOZ INC]	11
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CEFDINIR CAPSULE [SANDOZ INC]	11
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEFDINIR CAPSULE [SANDOZ INC]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFDINIR CAPSULE [SANDOZ INC]	11
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	CEFDINIR CAPSULE [SANDOZ INC]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR CAPSULE [SANDOZ INC]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFDINIR CAPSULE [SANDOZ INC]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-2176	CEFDINIR CAPSULE [SANDOZ INC]	14	Current NDC, Legacy NDC, 6 package rows	20200416_38f6adf7-e26c-4764-8ec9-360813874dd4.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefdinir	CEFDINIR	Sandoz Inc	38f6adf7-e26c-4764-8ec9-360813874dd4	2020-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065330 application number: ANDA065330 ndc (product): 0781-2176
Cefdinir	CEFDINIR	Proficient Rx LP	f30d01e3-0839-4928-a45a-b46c89aa454c	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065330 application number: ANDA065330

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CI0FAO63WC	CEFDINIR	91832-40-5	CEFDINIR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200346	cefdinir 300 MG Oral Capsule	PSN	38f6adf7-e26c-4764-8ec9-360813874dd4	14
200346	cefdinir 300 MG Oral Capsule	SCD	38f6adf7-e26c-4764-8ec9-360813874dd4	14
200346	cefdinir 300 MG Oral Capsule	PSN	4185590d-0197-72bb-e054-00144ff88e88	6
200346	cefdinir 300 MG Oral Capsule	SCD	4185590d-0197-72bb-e054-00144ff88e88	6
200346	cefdinir 300 MG Oral Capsule	PSN	76a31bff-99f3-e0d5-e053-2991aa0a00fa	3
200346	cefdinir 300 MG Oral Capsule	PSN	f30d01e3-0839-4928-a45a-b46c89aa454c	3
200346	cefdinir 300 MG Oral Capsule	SCD	76a31bff-99f3-e0d5-e053-2991aa0a00fa	3
200346	cefdinir 300 MG Oral Capsule	SCD	f30d01e3-0839-4928-a45a-b46c89aa454c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-2176-01	00781217601	100 CAPSULE in 1 BOTTLE (0781-2176-01)	100 capsule	2007-04-06	0000-00-00	No	No	Current
0781-2176-60	00781217660	60 CAPSULE in 1 BOTTLE (0781-2176-60)	60 capsule	2007-04-06	0000-00-00	No	No	Current
0781-2176-64	00781217664	3 CARTON in 1 CARTON (0781-2176-64) / 1 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK	3 carton	2007-04-06	0000-00-00	No	No	Current
0781-2176-69	00781217669	5 BLISTER PACK in 1 CARTON (0781-2176-69) / 10 CAPSULE in 1 BLISTER PACK	5 blister pack	2007-04-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefdinir - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	6
Cefdinir Capsules	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-04	HUMAN PRESCRIPTION DRUG LABEL	3
Cefdinir Capsules	Preferred Pharmaceuticals Inc.	2020-04-13	HUMAN PRESCRIPTION DRUG LABEL	3
Cefdinir Capsules Rx Only	Sandoz Inc	2020-02-24	HUMAN PRESCRIPTION DRUG LABEL	14
Cefdinir Capsules	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3